Physicians Office Resource - February 2024

Physicians office Resource 2024 | Issue 2

Resources for You, Your Patients, & Your Practice

Gene Therapy:

Precision in the Laboratory and in the Body MDescapes: A Picture-Perfect Place to Play — Turtle Bay Resort

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2024 · ISSUE 2 | 3

TABLE OF CONTENTS

Gene Therapy: Precision in the Laboratory and in the Body

Gene therapy, a groundbreaking field in medical science, holds the promise of revolutionizing the way we treat and potentially cure a wide range of genetic disorders. This innovative approach involves the introduction, alteration, or replacement of genetic material within a patient's cells to correct or eliminate the root cause of a disease. Over the past few decades, gene therapy has evolved from a theoretical concept to a rapidly advancing field with significant clinical implications, with several gene therapy drug receiving approval from the FDA. PAGE 6

18

32

Welcome to the Ozempic Effect: Unless you have been on a secluded island... it’s impossible to escape the Ozempic effect.

MDescapes: A picture-perfect place to play — Turtle Bay Resort

4 | PHYSICIANS OFFICE RESOURCE

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FEATURE

Gene Therapy: Precision in the Laboratory and in the Body

BY PHYSICIANS OFFICE RESOURCE

6 | PHYSICIANS OFFICE RESOURCE

Gene therapy, a groundbreaking field in medical science, holds the promise of revolutionizing the way we treat and potentially cure a wide range of genetic disorders. This innovative approach involves the introduction, alteration, or replacement of genetic material within a patient’s cells to correct or eliminate the root cause of a disease. Over the past few decades, gene therapy has evolved from a theoretical concept to a rapidly advancing field with significant clinical implications, with several gene therapy drug receiving approval from the FDA. Understanding Gene Therapy Gene therapy aims to address genetic abnormalities by introducing functional genes or modifying existing ones. In this article, we’ll look at the two primary types of gene therapy: ex-vivo gene therapy and in-vivo gene therapy, their methods and applications.

Ex-vivo Gene Therapy – Precision in the Laboratory Ex-vivo gene therapy is a type of gene therapy where the manipulation of genetic material occurs outside the patient’s body (ex-vivo means “outside the living body” in Latin). In this approach, cells are first removed from the patient, genetically modified in a laboratory setting, and then reintroduced into the patient’s body. This process allows for precise modification and control over the introduced genetic material before it is administered to the patient.

The general steps involved in ex-vivo gene therapy are as follows: 1. Cell Collection: Cells, usually from the patient (autologous cells), are collected through a process known as apheresis. Apheresis involves withdrawing blood from the patient, separating out specific cells (often stem cells or immune cells), and returning the remaining blood components to the patient.

2. Genetic Modification: In the laboratory, the collected cells are genetically modified to introduce, alter, or replace specific genes. This modification may involve correcting genetic mutations, adding therapeutic genes, or enhancing the cells’ ability to carry out a desired function.

3. Cell Expansion: After genetic modification, the cells are typically cultured and allowed to multiply or expand in number. This step ensures that a sufficient quantity of modified cells is available for therapeutic purposes.

4. Quality Control: The modified cells undergo thorough quality control testing to ensure that they meet safety and efficacy standards. This includes verifying the correct genetic modification, assessing cell viability, and confirming the absence of contaminants.

5. Patient Preconditioning: Before reintroducing the modified cells into the patient, some ex-vivo gene therapies may involve preconditioning the patient. This

may include procedures such as chemotherapy to create a more favorable environment for the modified cells to engraft and function effectively.

6. Cell Infusion: The modified cells are infused back into the patient’s body, often through intravenous injection.

Once inside the patient, the modified cells can exert their therapeutic effects, such as producing a missing protein, enhancing the immune response, or targeting specific disease cells.

Ex-vivo gene therapy is employed in various medical applications, including: 1. Hematopoietic Stem Cell Transplantation (HSCT): Ex-vivo gene therapy is commonly used in HSCT for the treatment of certain genetic disorders, such as severe combined immunodeficiency (SCID) or certain types of anemia. Hematopoietic stem cells are genetically modified to correct the underlying genetic defect before being infused back into the patient.

2. CAR-T Cell Therapy: Chimeric Antigen Receptor T-cell (CAR-T) therapy is a type of ex-vivo gene therapy used in the treatment of certain cancers. T cells are extracted from the patient, genetically modified to express a specific receptor targeting cancer cells, expanded in the laboratory, and then infused back into the patient to attack cancer cells.

Ex-vivo gene therapy offers several advantages, including the ability to precisely control the genetic modification process, perform thorough quality control, and tailor the therapy to individual patients. However, the process can be complex, and it may involve additional steps such as conditioning the patient and ensuring the survival and functionality of the modified cells after infusion.

In-vivo Gene Therapy – Precision in the Body In-vivo gene therapy is a type of gene therapy where the introduction, alteration, or replacement of genetic material occurs directly within the patient’s body (in-vivo means “within the living body” in Latin). Unlike ex-vivo gene therapy, which involves manipulating cells outside the body before reintroducing them, in-vivo gene therapy directly targets the cells or tissues within the patient to achieve the desired therapeutic effect.

Key features of in-vivo gene therapy include: 1. Direct Delivery to Target Cells: In in-vivo gene therapy, therapeutic genes or genetic material are delivered directly to the target cells or tissues within the patient’s body. This can be achieved using various delivery methods, such as viral vectors, nanoparticles, or other delivery systems.

2. Precise Targeting: The goal of in-vivo gene therapy is to precisely target the affected cells or tissues without the need for cell extraction or manipulation outside the body.

This approach aims to deliver therapeutic genes specifically to the site of action, minimizing off-target effects.

2024 · ISSUE 2 | 7

FEATURE

3. Reduced Complexity: In comparison to ex-vivo gene therapy, in-vivo gene therapy is often considered less complex, as it eliminates the need for cell collection, ex-vivo manipulation, and subsequent reintroduction of cells into the patient.

4. Minimized Invasiveness: In-vivo gene therapy procedures are designed to be minimally invasive, involving the direct administration of genetic material to the target cells or tissues. This can be achieved through injection, infusion, or other delivery methods depending on the specific therapeutic goals and target organs.

In-vivo gene therapy is used in various medical applications, including: 1. Gene Augmentation: In certain genetic disorders where a specific gene is deficient or mutated, in-vivo gene therapy aims to introduce a functional copy of the gene directly into the affected cells to restore normal function.

2. Gene Silencing: In-vivo gene therapy can also involve the delivery of therapeutic agents, such as RNA interference (RNAi) molecules, to silence or inhibit the expression of a specific gene associated with disease.

3. Gene Editing: Advanced gene-editing technologies, such as CRISPR-Cas9, can be employed in in-vivo gene therapy to directly modify the DNA within target cells, correcting genetic mutations or introducing specific changes.

2. Cancer: Gene therapy is being explored as a potential treatment for cancer by targeting and modifying the genes responsible for uncontrolled cell growth.

3. Neurological Disorders: Diseases like Parkinson’s and Alzheimer’s, which have a genetic component, are being investigated for gene therapy interventions to slow or halt disease progression.

4. Cardiovascular Diseases: Gene therapy holds potential for treating heart diseases by enhancing the function of specific genes involved in cardiac health.

5. Inherited Blindness: Clinical trials have demonstrated success in treating certain forms of inherited blindness by introducing functional genes to restore vision.

Challenges and Ethical Considerations While gene therapy offers exciting possibilities, several challenges must be addressed: Targeting the correct genes and cell: One difficulty has been making sure a treatment gene targets in on the correct cells in the correct tissue. Not only that, but that the therapy is delivered into millions of these cells rather than just a few, all without disrupting the function of nearby genes.

Delivery Systems: Efficient and safe delivery of therapeutic genes to target cells remains a significant hurdle. Researchers are exploring various vectors, such as viruses and nanoparticles, to enhance gene delivery.

4. Viral Vector Delivery: Viral vectors, modified viruses that cannot cause disease but can deliver therapeutic genes, are commonly used in in-vivo gene therapy. These vectors efficiently transport genetic material into target cells, facilitating gene expression.

Immune Response: The body’s immune system may react to the introduced genetic material or delivery vectors, posing potential safety concerns. Ongoing research aims to minimize immune reactions and improve the long-term effectiveness of gene therapies.

In-vivo gene therapy has shown promise in treating a variety of diseases, including genetic disorders, certain types of cancer, and acquired conditions. While it offers advantages in terms of simplicity and direct targeting, challenges such as effective delivery to specific tissues, potential immune responses, and the need for precise control over gene expression are areas of ongoing research and development in the field. As technologies continue to advance, in-vivo gene therapy holds the potential to become a widely used and powerful tool in the treatment of various medical conditions.

Ethical Dilemmas: Germline gene therapy raises ethical concerns, as modifying reproductive cells could have far-reaching consequences for future generations. Balancing the potential benefits with ethical considerations is crucial in shaping the future of this technology.

Applications of Gene Therapy Gene therapy has shown promise in treating a variety of genetic disorders, including: 1. Genetic Disorders: Conditions caused by mutations in single genes, such as cystic fibrosis, muscular dystrophy, and hemophilia, are prime candidates for gene therapy.

8 | PHYSICIANS OFFICE RESOURCE

The dynamic interplay between ex-vivo and in-vivo gene therapy approaches marks an exciting era in medical innovation. As these technologies continue to advance, the dream of treating and curing genetic disorders becomes increasingly tangible. The dual perspectives of ex-vivo precision in the laboratory and in-vivo direct targeting within the body represent a powerful synergy that holds immense promise for the future of medicine. The journey toward unlocking the full potential of gene therapy is ongoing, with each breakthrough paving the way for a new era of personalized and transformative healthcare.

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2024 · ISSUE 2 | 11

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2024 · ISSUE 2 | 13

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FEATURE

WELCOME TO THE

OZEMPIC EFFECT

BY DAVID KLIFF OF THE DIABETIC INVESTOR

Think about this just for a moment. When was the last time a patient walked into your office and practically demanded that you put them on a drug? When was the last time these same patients said, “cost be damned, I don’t care that it’s going to cost me over $1,000 a month. I want to be on this drug.” How often do these patients give you the I really don’t care look when you explain this is a diabetes drug, they don’t have diabetes, and as good as these drugs are, there are side effects, they need to be aware of.

18 | PHYSICIANS OFFICE RESOURCE

Welcome to what we call The Ozempic Effect. Ozempic is one of three drugs that is currently taking the world by storm. The other two are Wegovy also from Novo Nordisk (the makers of Ozempic) and Mounjaro from Eli Lilly. We might as well throw Rybelsus from Novo Nordisk into the mix; and currently the only oral GLP-1 on the market. Of these four, only Wegovy is FDA approved to treat obesity, with Lilly expected to get the same approval for Mounjaro anytime now.

Now unless you have been on a secluded island with no communication to the outside world, it’s impossible to escape the Ozempic effect.

Authors have written extensive opinion pieces on feeling guilty using these drugs to lose weight when they themselves do not have diabetes. Others have opined about the inequities in the healthcare system as the patients who need these therapies cannot afford them. Wal-Mart has stated they have noticed a change in customer buying habits and airlines have talked about the future size of airline seats.

Celebrities such as Lady Gaga who lose weight are being called out for using the drug.

Shares in diabetes device companies such as Dexcom and Insulet have been hammered as analysts have the false impression that patients will no longer use CGM or insulin pumps. Not surprisingly shares of Lilly and Novo are hitting new highs. Novo is making so much money they cannot spend it fast enough. An entire subculture is developing to make money off these drugs some legit many not.

So, let’s separate fact from fiction: 1. This cannot be understated, NONE of these therapies are approved for patients with Type 1 diabetes.

2. Ozempic, Wegovy and Mounjaro are all once-weekly INJECTIONS. 3. Rybelsus the only oral in the category has strict dosing protocols which if not followed make the drug ineffective.

4. Like any therapy, there are possibilities of adverse events.

5. These therapies also may not work in every case.

6. All are very effective at weight loss however the patient MUST remain on the drug to keep the weight off.

7. No question, cost is a factor and will impact patients who are not financially equipped. Reimbursement is improving but still remains an issue and as of this writing these drugs are NOT covered by Medicare.

8. This also cannot be understated as the data is beyond compelling, besides the weight loss, patients are seeing corresponding improvements in comorbidities associated with obesity.

FEATURE

Now unless you have been on a secluded island with no communication to the outside world, it’s impossible to escape the Ozempic effect. Ozempic has gone from a diabetes therapy to a worldwide phenomenon. Ozempic and the others aren’t just making news in the medical community, they are making news in the mainstream media and allover social media. Shortages of these therapies created by the insatiable demand have created a true black market.

9. The injections are not painful, and each come with a very patient friendly delivery system, except for Rybelsus.

10. Yes, more than a few patients experience real guilt from using these therapies. While they enjoy the weight loss, many accuse them of “cheating.” Do not underestimate this fact and do your best to prepare patients for this very real dynamic.

11. There is empirical evidence that these therapies also help patients with Type 1 diabetes but as we stated when we began, they are not currently approved for Type 1 patients.

Typically, in case such as this we would advise having a frank discussion with the patient. But here too the Ozempic effect comes into play as patients are already well informed.

Many physicians we have spoken with have noted that try as they might to discuss things their information falls on deaf ears. The bottom line is these people see these drugs as an easy path to weight loss and it’s hard to blame them.

There is no behavior change, no going to the gym just one injection a week.

We hate to oversimplify here but the drugs make the patient feel full, so they eat less. Talking with many patients using the therapies they literally say the drugs have changed their lives. Many could lose weight but couldn’t keep it off, others no matter how hard they tired couldn’t lose weight. More than one has called their therapy a miracle. Frankly it’s astonishing as I have been writing about and living with Type 1 diabetes for over 30 years and have never seen anything close to this.

Here’s the crazy part, as good as these therapies are Novo, Lilly and others have even better therapies under development. Thankfully perceptions are also changing as obesity is no longer seen as a character flaw that it’s a real disease just as diabetes is a very real disease. Heck, Weight Watchers, Noom, and others have thrown in the towel and are actively endorsing these drugs. Advocates of weight loss through behavior change are struggling to compete.

There is no question The Ozempic Effect is very real and has forever changed the treatment paradigm.

2024 · ISSUE 2 | 19

PRODUCT FOCUS

CLIA WAIVED ULTRA HCG COMBO TEST

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From Sekisui Diagnostics The OSOM® Ultra hCG Combo test is a simple immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Internal studies have confirmed that the OSOM® Ultra hCG Combo test does not have a false negative result from hCG variants providing physicians with a higher level of confidence.

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FIRST EVER CLIA WAIVED HEMATOLOGY ANALYZER

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From Sysmex Faster test results, clinical decisions and greater practice efficiency are coming to physicians’ offices with the first CLIA-waived CBC analyzer. Hematology diagnostics leader Sysmex is bringing more lab testing to the point of care.

One of the most common blood tests can be conducted reliably and accurately on-site, in as few as three minutes.

The device’s ease of use and innovative technology means in-house staff can operate it in just a few easy steps, without lengthy certification and training. The new Sysmex XW-100 will improve health care efficiency and patient care.

View Brochures, Videos & Mores at POR.io Enter Number 3631 in the Search Area

COVID-19 TESTING

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BD VERITOR™ PLUS SYSTEM From BD Veritor™

The BD Veritor™ Plus System is a portable, easy-to-use, testing solution for SARS-COV-2*, Flu A+ B and other respiratory tract infections that delivers results in 15 minutes or less. It features two analysis modes that adapt to your workflow, online education tools, and optional reporting capabilities including the BD Synapsys™ Informatics Solution—making it the point-ofcare diagnostic tool you won’t want to be without. *EUA authorized by FDA

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20 | PHYSICIANS OFFICE RESOURCE

COVID-19 TESTING WHY COMPROMISE? FAST AND RELIABLE RESULTS ARE NOW DELIVERED AT THE POINT OF CARE.

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From LumiraDx

Introducing the next generation in point-of-care diagnostics.

With a growing menu of tests, LumiraDx uses a simple process that allows for more time with your patients by using microfluidic technology that delivers results in minutes. Learn more about rapid COVID-19 diagnostic solutions for your physician office at LumiraDx.com.

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SOFIA® 2 FLUORESCENT IMMUNOASSAY ANALYZER AND RAPID DIAGNOSTIC TEST KITS 3634

From Quidel

Sofia® 2 Fluorescent Immunoassay Analyzer and Rapid Diagnostic Test Kits Sofia 2 takes rapid testing to a new level.

Proven lateral-flow technology and advanced fluorescent chemistry are all integrated into this small benchtop analyzer which can be used in any point-of-care setting. Sofia 2 kits are easy to use and adaptable to any healthcare setting. Excellent performance, objectivity, quality control, LIS capabilities, and an expanding test menu make Sofia 2 the perfect solution for the physician’s office laboratory.

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BE PREPARED FOR RESPIRATORY SEASONS WITH THE OSOM® COVID-19 ANTIGEN RAPID TEST

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From Sekisui The OSOM® COVID-19 Antigen Rapid Test is a lateral flow immunoassay that detects the SARS-CoV-2 nucleocapsid protein with a nasal swab in only 15 minutes at the point-of-care. The test is intended to be used by healthcare professionals or operators on patients suspected of COVID-19 within the first 7 days of symptom onset. The clinical performance compares favorably against polymerase chain reaction methodology, with a positive percent agreement of 95.1% and a negative percent agreement of 97%.

View Brochures, Videos & More at POR.io Enter Number 3635 in the Search Area OSOM® COVID-19 Antigen Rapid Test has not been FDA cleared or approved. It is authorized by FDA under an EUA for prescription use only. It has been authorized only for the detection of SARS-CoV-2 antigen, not for any other viruses or pathogens and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C S360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

2024 · ISSUE 2 | 21

DIABETES/BLOOD GLUCOSE QUANTAFLO® PAD PRODUCT FOCUS

From Semler Scientific QuantaFlo® PAD is an easy to use, accurate, point of care, noninvasive solution that aids in the early detection of peripheral arterial disease (PAD). This FDA cleared device can be administered by a medical aide in less than 5 minutes. As published in the Journal of Vascular Surgery and the American Journal of Preventive Medicine, QuantaFlo detected undiagnosed PAD in 31.6% of patients +65.1 QuantaFlo is portable and integrates with other technologies and platforms. It is ideal for both home and clinic environments.

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1. Smolderen KG, Ameli O, Chaisson CE, Heath K, Mena-Hurtado C. Peripheral Artery Disease Screening in the Community and 1-Year Mortality, Cardiovascular Events, and Adverse Limb Events, AJPM Focus (2022), https://doi.org/10.1016/j.focus.2022.100016

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NOVA PRIMARY BLOOD GLUCOSE REFERENCE ANALYZER From Nova Biomedical

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The U.S. FDA has cleared Nova Primary as a blood glucose reference analyzer that fills the need for a new reference analyzer to replace the YSI STAT PLUS 2300 (YSI, Inc., Yellow Springs, OH).

Manufacturers of blood glucose measuring devices and clinical diabetes researchers have relied on the YSI 2300 as a reference and correlation analyzer. However, YSI, Inc. no longer supports the analyzer, and its discontinuation has left a critical industry void.

With today’s FDA clearance, Nova Primary from Nova Biomedical is now available in the U.S. and worldwide.

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3638

COMPREHENSIVE IN-OFFICE DIABETES TESTING WITH THE DCA VANTAGE® AND CLINITEK STATUS®+ ANALYZERS From Siemens Healthineers Siemens Healthineers DCA Vantage® and CLINITEK Status® family of analyzers provide hemoglobin A1c (HbA1c) and albumin-tocreatinine ratio (ACR) testing at the point of care. Meet quality measures for A1c control and kidney disease check in minutes with CLIA-waived HbA1c testing and ACR1 ratio. Improve patient experience and overall outcome by providing actionable results in minutes.

1. Moderately complex on the DCA Vantage Analyzer. CLIA-waived on the CLINITEK Status+ Analyzer.

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THE POWER TO DETECT THE HIDDEN THREAT OF PERIPHERAL ARTERIAL DISEASE (PAD) 3639

“PAD IS ASYMPTOMATIC IN 75% OF ELDERLY PATIENTS.” 1

IN PRIMARY CARE: “THE RISK OF MORTALITY WAS SIMILAR IN SYMPTOMATIC AND ASYMPTOMATIC PATIENTS WITH PAD” 2

BOOK YOUR FREE DEMO CONTACT US TODAY AT 888-340-4881, 5 OR INFO@SEMLERSCIENTIFIC.COM

SEMLERSCIENTIFIC.COM

1. Sillesen, H., & Falk, E. (2011). Peripheral artery disease (PAD) screening in the asymptomatic population: why, how, and who?. Current atherosclerosis reports, 13(5), 390–395. https://doi.org/10.1007/s11883-011-0196-x 2. Diehm, C., Allenberg, J. R., Pittrow, D., Mahn, M., Tepohl, G., Haberl, R. L., Darius, H., Burghaus, I., Trampisch, H. J., & German Epidemiological Trial on Ankle Brachial Index Study Group (2009). Mortality and vascular morbidity in older adults with asymptomatic versus symptomatic peripheral artery disease. Circulation, 120(21), 2053–2061. https://doi.org/10.1161/CIRCULATIONAHA.109.865600 ML00190 Rev A

PRODUCT FOCUS

HEMATOLOGY HEMATOLOGY TESTING MADE EASY From Sysmex Designed for labs testing up to 25 samples per day, the Sysmex pocH-100i™ has the smallest footprint of any analyzer on the market. The instrument requires only 15uL of whole blood for reporting of 17 clinical parameters, including a 3-part WBC Differential. It is ideal for urgent care, physician office lab, small clinic, or any outpatient setting where a point of care CBC is needed.

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TURN SMALL PLACES INTO SMART SPACES From Abbott

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With reduced budgets, shrinking laboratory space and staffing challenges, many laboratories need a solution that lets them work smarter with less. The CELL-DYN Emerald 22 AL is a full performance, automated optical 5-part differential analyzer that delivers smarter results for small to midsize clinical laboratories.

• Compact Design • Walkaway Functionality • Ease Of Use • Smart Safety Features

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MICROS HEMATOLOGY ANALYZER WITH 3-PART DIFFERENTIAL PLUS THE LITEDM From HORIBA Medical

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Is it viral or bacterial? A CBC with 3-part differential can provide the clues to help distinguish between viral and bacterial infections before you decide to treat. The Micros 60 Hematology analyzer provides a CBC with 3-part Diff result in less than 60 seconds using only 10 µL of sample. Connect to the LiteDM Patient Data Management System for an affordable way to consolidate patient results to one report.

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24 | PHYSICIANS OFFICE RESOURCE

Persooal foaoue eduuatioon tailored to you.

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Get our mobile app for free.

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FLU AND RESPIRATORY PRODUCT FOCUS

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BIOFIRE SPOTFIRE From bioMerieux bioMérieux knows that an evolving world deserves evolved diagnostics. Our latest innovation, the BIOFIRE® SPOTFIRE® Respiratory Solution, is the first FDA-cleared and CLIA-waived COVID-19 testing solution. The BIOFIRE® SPOTFIRE® System is an easy-to-use system that runs the BIOFIRE® SPOTFIRE® Respiratory (R) Panel. Benefits of the SPOTFIRE Respiratory Solution include: 15 respiratory targets on 1 PCR test with results in about 15 minutes; minimal benchtop space with vertical scalability up to four modules; easy to use with an intuitive user interface.

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ACUCY INFLUENZA A&B TEST From Sekisui Diagnostics The Acucy™ Influenza A&B Test is for the rapid, qualitative detection of influenza A and B viral nucleoprotein antigens from both nasal and nasopharyngeal swabs.

Utilizing the Acucy™ Reader in either the point-of-care or laboratory setting, workflow flexibility is achieved with both Read Now and Walk Away features. The combination provides clinicians with standardized and definitive result interpretation.

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3645

OSOM ULTRA PLUS FLU A&B TEST From Sekisui Diagnostics 3646

Stronger Clinical Performance Takes Lateral Flow Testing To The Next Level. Providing superior rapid results at the point-of-care.

Fast, easy, cost effective so you can test and treat in one visit.

• High Performance- Equivalent or exceeding the performance of reader devices, without the need for an instrument • Results in 10 minutes • OSOM® Custom Care- Exceptional Support/Training by licensed medical technologists and experienced healthcare professionals • Made in the USA

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26 | PHYSICIANS OFFICE RESOURCE

3647

PERIPHERAL ARTERIAL DISEASE QUANTAFLO® HD PRODUCT FOCUS

From Semler Scientific The QuantaFlo® HD application assists in the early detection of Heart Dysfunction (HD). As published in the Journal of Preventive Medicine, QuantaFlo HD showed a statistically significant correlation with cardiac echocardiography, which is a gold standard for diagnosing heart failure.1 The test is highly sensitive, able to detect even asymptomatic HD, and can be performed in the outpatient clinic or the home setting in approximately 5 mins. Results are available immediately and graded as either positive or negative for HD allowing for improved patient selection for echocardiography.

1. Howell, S. C., & Master, R. C. (2023). Clinical Evaluation of Volume Plethysmography as an Aid for Diagnosis of Heart Failure in the Primary Care Setting. Journal of Preventive Medicine, 8(2). https://doi.org/https://preventive-medicine.imedpub.com/clinical-evaluation-of-volume-

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plethysmography-as-an-aid-for-diagnosis-of-heart-failure-in-the-primary-care-setting.pdf

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PAD TESTING SYSTEMS IDEAL FOR PRIMARY CARE TO VASCULAR SPECIALISTS from Newman Medical Your Patients Trust YOU To Find Their Peripheral Artery Disease • High-risk patients include those over 65, diabetics, and smokers.

• If left untreated, 25% of patients with PAD will experience a heart attack or stroke within 5 years.

• PAD symptoms are often mistaken for arthritis or old age.

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The simpleABI Cuff-Link System is Easy to Learn and Use. • With a push-button remote, automatic calculations, and waveforms, it’s incredibly user-friendly.

• Reports are straightforward to save and share since the system is PC-based.

Outstanding Value and Reimbursements • The system pays for itself in less than a year with just one test per week.

• Medicare reimbursements vary by exam and location, averaging from $91 to $174.

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SYNDROMIC TESTING BIOFIRE® FILMARRAY® TORCH From bioMérieux 3650

The BIOFIRE® FILMARRAY® TORCH is a fully integrated, random, and continuous-access system designed to meet your laboratory’s syndromic infectious disease testing needs. The benchtop footprint of the BIOFIRE TORCH saves precious lab space, and its scalability meets high throughput demands. BIOFIRE® FILMARRAY® Link Software automatically uploads patient results. Fully compatible with all BIOFIRE® FILMARRAY® Panels intended for use in CLIA-moderate settings, the BIOFIRE TORCH helps you maximize efficiency and productivity.

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3651

3652

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WOMEN'S HEALTH PRODUCT FOCUS

OSOM® BVBLUE® 3654

From Sekisui Diagnostics The OSOM® BVBLUE® detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus. OSOM® BVBLUE® is more sensitive than Amsel criteria providing physicians with a more accurate diagnosis to treat and minimize serious health consequences such as early spontaneous preterm births and miscarriage.

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OSOM® TRICHOMONAS RAPID TEST From Sekisui Diagnostics The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis antigens from vaginal swabs or from the saline solution. The OSOM® Trichomonas Rapid Test is a CLIA-waived rapid test available today. OSOM® Trichomonas is more sensitive than wet mount due to the assay being able to detect viable and non-viable organisms which offers significant benefits to the patient and clinician alike.

View Brochures, Videos & More at POR.io Enter Number 3655 in the Search Area

3656

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ULTRA HCG COMBO TEST From Sekisui Diagnostics The OSOM® Ultra hCG Combo test is a simple immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Internal studies have confirmed that the OSOM® Ultra hCG Combo test does not have a false negative result from hCG variants providing physicians with a higher level of confidence.

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30 | PHYSICIANS OFFICE RESOURCE

3657

A PICTURE-PERFECT PLACE TO PLAY

TURTLE BAY RESORT

BY BRANDI BROWER, TRAVEL EDITOR

32 | PHYSICIANS OFFICE RESOURCE

As I look out my window, a blanket of white spreads out as far as the tree line and the mountain range in the distance. It’s winter. I grew up with all four seasons, and the older I get, the less I like shoveling snow, and the more I dream of escaping somewhere tropical.

The fallback plan is to reminisce about my most recent taste of the tropics during my adventure in Hawaii. The North Shore of Oahu, to be exact. The award-winning, secluded, and exceptional property is the Turtle Bay Resort. Flying into Honolulu, the juxtaposition of many skyscrapers towering over the palm trees below is odd. But this is the capital of Hawaii and the central hub for business, finance, hospitality, and military defense, with a population of close to a million. So, it makes sense to see so much concrete in the jungle. Even though the architecture screams the seventies, the Don Ho heyday of Hawaii, there is a vibe of nostalgia when times were simpler, and everyone wanted to “hang loose!”

The populated and high tourist traffic area of Honolulu and the famous Waikiki Beach are a world away from the almost country-like quiet of the Northern region. There seems to be a dichotomy at play between the South and North Shore - the melting pot of tourism, high-end shopping, industry, and politics of Honolulu, and just an hour’s drive along HI-83, you’re in a completely different place, with farmstands dotting the roadside and kids barefoot on bikes with boogie boards under their arms. If landing in Hawaii was an exhale moment, arriving at the North Shore took my breath away.

I can see my breath as I walk out to my mailbox. Under the recent wind chill advisory issued by the weather service with a “feels like” temp of 12 degrees below zero, my reality makes me “feel like” I want to return to 80 degrees and sunny in Turtle Bay. Of the main Hawaiian islands, Oahu is driest regarding the weather. You can’t have a bad weather day with the shining sun year-long most of the time, usually along the coast; it’s practically perfect. With the consistency of gorgeous weather combined with the quiet comfort of the pristine North Shore, it’s a recipe for respite.

Laid back five-star luxury, the Turtle Bay Resort is not only the oldest and venerable landmark on the block but also the only one on the block. The iconic property celebrated its 50th anniversary in 2023 and has been the grand dame of Oahu’s North Shore for half a century. Sprawling over 1300 lush acres of natural landscape and historic land, with miles and miles of wild coastline real estate to explore, on the edge of Kuilima Point in Kahuku, there’s reason to celebrate the longevity of the peninsula paradise. They are the only ones on the block because they own the block.

Hawaii is the hale (or home) of surfing; it’s where it all began.

The ritual, the boards, the ride, and the vibe -it’s woven within the culture. The “Seven Mile Miracle” is within that history, a concentrated stretch of 36 surf spots along a distinct section of Kamehameha Highway and the celebrated mecca of worldclass surf breaks. Just up the road from this stretch of surfing nirvana is the Turtle Bay Resort. Unsurprisingly, the resort em-

braced the surfing scene and wave-chasing culture of the North Shore, capitalizing on that cool aesthetic when completing the 250-million-dollar/several-year renovation project. Taking advantage of the Covid downturn, the transformative transition, courtesy of Dianna Wong Architecture + Interior Design, the resort was taken down to the studs and built back up in terms of its entire foundation and structure. With the refurbishment of its 450 guest rooms, 42 high-end bungalows, and the opening of a new 11,000 square foot spa, along with two new restaurants and bar, the decor, sprinkled with hints and homages to the surfing culture, enhances the unique property. The designer replaced the kitschy lava rock and classic aloha decor with a light and inviting subtle color palette, weaving in linen, wicker, and other natural fibers to brighten the once-dark spaces.

The dramatic entrance to the porte-cochère is a circular driveway lined with 15-foot surfboards. The exterior of the actual Y-shaped premises isn’t particularly impressive. However, when I realized the method to the madness, with the three-pronged building on the peninsula, every side of the building had a view 2024 · ISSUE 1 | 33

of the ocean, and every guest was greeted with an oceanview room. Even more dramatic is the expansive lobby. Pre-renovation, one side of the lobby housed executive/admin offices.

Thanks to the reimagining of Hilo native and award-winning architect Rob Iopa, walls were replaced with windows, opening up the opportunity for panoramic views, a complete open-air space, and a gorgeous gathering hotspot for the guests both day and night. Clusters of conversation seating areas include a few larger rounded bench bays with large open-air circular skylights above for stargazing and cozy firepits below. The Off the Lip lobby bar is tucked between these seated sections, offering craft cocktails and snacks while watching the pool plunging below.

Greeted with the traditional floral lei, the host also offered one of their famous banana bread lattes, a popular item at the Ho’olana eatery onsite, offering coffee, smoothies, and quick bites for breakfast and lunch. I hop into a golf cart to get a lay of the “crown land” upon which the resort rests, once ruled by King Kamehameha III. My guide takes me along endless sandy/ dirt paths, meandering through the 12 miles of trails to utilize and passing by three separate serene beaches - one so picturesque that it is featured in several films. I’ll follow up with more on that fact.

We drive across the road to the on-property farm at the resort.

Having your food source onsite makes being a fully sustainable resort easier. The beautiful 468 acres of lush agriculture provide 700 lbs. of produce for use weekly in the resort’s varied menu offerings and libations, and the on-property farm serves the 34 | PHYSICIANS OFFICE RESOURCE

surrounding community. Kuilima Farm offers its bounty at the colorful roadside stands and provides leasing space to local farmers for community gardening and training in responsible farming practices. Kuilima Farms was a surprise feature on the Turtle Bay tour that reflected not only the natural beauty of the island but also the concentrated efforts to stay deeply connected to the land itself. *Try the Banana Lumpia, where brown sugar, fruit, and deep fry collide - a farmstand fave.

You know you are at a unique beach resort when it features an onsite equestrian facility: the token tractor, antique-looking wooden wagon, charming red-painted barn, and a coral of pretty ponies, all abutting an ocean yards away. There are many offerings for horseback riding for both young and old, all beginning and ending on this appointed plot. This spot is also the perfect backdrop for the weekly Paniolo, Hawaiian Cowboy Luau. The traditional Hawaiian feast with a twist: Paniolo [pahnee-oh-loh] A person who herds cattle; cowboy - is the theme of the Thursday evening event celebrating Hawaii’s rich cowboy and ranching heritage. The pai’na (dinner party) features some traditional fare accented with Southwestern/South American influences. A few highlights included grass-fed meat from local Hawaiian ranches smoked for 11 hours in preparation for the buffet feast, the vintage horse trailers retrofitted into a cash bar, and the live entertainment.

As the tour of the property winds down, we pass by the infamous Banyan tree along one of the many paths. This impressive tree spans over a hundred feet tall. Its expansive aerial root system extends from its branches—a striking backdrop just feet

away from one of the beautiful secluded beaches, an excellent setting for movies—featured prominently in Pirates of the Caribbean, Hunger Games, and the T.V. series Lost. The Turtle Bay Resort is a popular spot for filming blockbuster hits and over 150 movies and television shows. With the gorgeous vegetation and dramatic volcanic mountain formations down to the magnificent ocean scapes, it’s a cinematic paradise. As I look out my window and see the piles of heavy snow and ice-laden tree limbs, it seems like a sequel to Stanley Kubrick’s famous film The Shining could be filmed here. I digress.

All rooms have an ocean view, but mine is spectacular as it is at the end of the building, which abuts the edge of the property overlooking the crashing waves against the volcanic rock, also facing west to soak up the unbelievable sunsets. This highly sought-after oceanfront club king suite is on the 6th floor; with the extended lanai, large chaise lounger for two, table, and chairs, it’s an inviting space for panoramic viewing of nature’s magic. The sliding doors open completely, so the outdoors feel a part of the suite. Rising in the morning to the sound of the rolling waves and the scent of the sea is a beautiful wake-up call. Even though I’m in the main building, the suite is massive.

It feels like it’s my private bungalow with a dining area and bank of cabinetry with a Nespresso machine and refrigerator, over to the living space with a comfy sleeper sofa and ottoman, with a large flat screen t.v. over a bank of six large dresser drawers and large standing closet as the endcap. On the opposite side of the room is an eye-catching floor-to-ceiling photo mural. The deep blues and turquoise green of the surfer p.o.v of the inside of a wave is a striking splash of color for the room that consists of casual beachcomber neutrals. The crisp white comforter is accented with the blonde-stained wooden headboard and floating shelf bedside tables. A slab panel door rolls on the track, opening into the bathroom, featuring a marble sink with a sizeable round-lit mirror above. Two glass-hinged doors, one for the toilet space and the other for the massive, walk-in stoned shower, are adjacent to an additional closet.

The practicality of a wooden pocket door for privacy or the opportunity to open up and take in the view of the ocean while bathing in the stand-alone bathtub is a bonus feature.

If you desire an even more secluded North Shore experience, the Ocean Bungalows at Turtle Bay are an indulgent option.

There are 42 oceanfront villas, 714 square feet of intimate space, with 15-foot vaulted ceilings, walk-in showers, soaking tubs, and patios, just a few steps from the beach. With a private infinity pool for bungalow guests only and a personal concierge assigned to you for your every whim, you can only imagine these beautiful accommodations were host to many actors filming on location. You’d feel like a movie star staying here.

If more than the spacious room, with the incredible view from the top floor, is needed, the access to the Ocean Club Lounge is the cherry on top. With the coveted suite, you can access the exclusive lounge, dedicated concierge service, and complimentary food and drinks in the private indoor/outdoor space overlooking the pools below and the beautiful bay beyond.

Wearing my waterproof wristband, which serves as my room key and entry into the lounge, I utilize this generous perk to my

visit. I frequented the curated cuisine daily for breakfast, lunch, and evening appetizer snacks, which are created with the fresh ingredients of the resort’s farm. *Try the Uncle’s Ku Aloha ice cream sandwiches made locally on the North Shore for a frosty treat.

The resort offers several dining options onsite: Beach House by Roy Yamaguchi is an open-air restaurant near Kuilima Cove.

Chef Roy shares his family’s favorite dishes and signature style using the freshest local ingredients from farmers, fishermen, and ranchers. An extension of the restaurant is the Beach Club, where service is rendered to you in comfy cabanas on the beach, soaking up the beach scene while consuming the delectable bites and cocktails from Roy’s just a stone’s throw away.

Lei Lei’s Bar and Grill, a local favorite, uses the golf course as the backdrop for casual cuisine. Alaia’ is known for its modern take on Hawaiian comfort fare, serving breakfast, lunch, and dinner. A great place to watch the sun dip down into the horizon while dining on delectable delights: Garden Beet Trio - Roasted Golden, Ruby Red Purée, Shaved Chioggia, Arugula, 2024 · ISSUE 2 | 35

it easy,” and “thank you.”

As the folklore goes, Kahuku Sugar Mill worker Hamana Kalili lost his middle three fingers on the job. After the accident, he was asked to be the security officer, in charge of the train running between Kaaawa and Sunset Beach. He was responsible for preventing kids from jumping on the train for a joy ride.

Whenever he spotted the kids attempting to hop on, he would yell and wave his hand. Seeing the wave of only a thumb and a little finger was strange. The stowaways soon adopted the wave as a signal to each other that the security guard Kalili was not looking; the coast was clear to hop onto the train.

Hawaiian Heart of Palm, Nasturtium Vinaigrette for a starter and the Ali’i Mushroom Tagliatelle - Mushroom Cream Sauce, Truffle Oil, Shaved Parmesan, with Jumbo Prawns, and ending with Mile High Turtle Bay PiePecan Cheesecake Hawaiian Sea Salt Caramel, Chocolate Cookie Crust.

Lastly, Sunset at Turtle Bay is the heart of the hotel. Next to the pools, this outdoor bar and eatery have the perfect vantage point to watch the surfers catching the last waves of the day while admiring the colorful display of the sun’s light disappearing. With tables and chairs scattered around the pool deck, live music, fire pits, and ocean breezes are an excellent combination for the chill atmosphere. *Try the Okonomiyaki Fries - house tare, wasabi aioli, ao nori, katsuo flakes, and green onion.

The resort experiences available to guests are extensive and listed daily, not surprisingly, on a surfboard near the concierge desk. My first outing was a kayak turtle-watching tour in Kawela Bay. Turtle Bay Resort is aptly named for the “Honu,” or green turtles that reside in the ocean, a significant animal to Hawaiian culture. Legend states that long ago, the green turtles were the original guides showing ancient Polynesians how to get to the Hawaiian islands. They are considered ancestral spirits, offering good luck, protection, peace, and longevity. It was an incredible opportunity to see these majestic island navigators swimming alongside the kayak and poking their heads up to say hello.

I also enjoyed the cultural bike tour on Murf electric beach bikes. The unique guided ride takes you to the several beaches on the property, along the two golf courses, and through the miles of trails on the 1300 acres. Our resort team member was born in the area and well versed in the storied past of the island kings. She pointed out the seven different “ahupua’a,” or traditional Hawaiian land divisions with distinct characteristics and history. She also shared the story of the “shaka.” The birth of “hang loose” or the “shaka” hand gesture was from this side of the island in the early 1900s. To make the shaka, you curl your three middle fingers while extending your thumb and baby finger. For emphasis, quickly turn your hand back and forth with your knuckles facing outward. This local expression of courtesy has other connotations like” “things are great,” “take 36 | PHYSICIANS OFFICE RESOURCE

Additional island adventures to consider: James O’Brien Surf Experience, onsite surf lessons for all ages and levels, two 18hole golf courses - Arnold Palmer and George Fazio design, as well as a newly added 18-hole putting course, four tennis and pickleball courts, helicopter tours, outrigger, Segway, paddleboard tours, mountain biking, even an island scavenger hunt.

There are several options for younger guests, including the Mermaid Academy, stargazing, lei-making, the Brave Mermaid Show, bird-watching, coconut frond weaving, ukulele and Hulu lessons, lawn games, beach picnics, pony meet and greet, night snorkeling.

Basking by the adults-only infinity pool on the terraced pool deck, laying on one of the in-pool shelf lounge chairs in the family-friendly pool, or watching little guests enjoy the two slides in the kids’ pool, the leisure water scene is a focal point of the resort, with plenty of cabanas, deck chairs, umbrellas, and staff to keep towels, food and beverages flowing. The aquatic area is perfectly positioned, with southern exposure for optimal sun, views of the volcanic peaks above, and the ocean’s swells below with the silhouettes of surfers on their boards, waiting for one last big wave of the day- a picture-perfect place to play.

A little rest and reset at the newly renovated Nula Spa. The 11,000-square-foot sprawl of design enhancement is the perfect space for specialty treatments and massages; it turns the resort into a retreat for mind, body, and spirit. An ocean oasis of self-care in outdoor cabanas and garden treatment rooms within earshot of the waves, choose from their extensive list of massages, facials, body treatments, and beautification with hair, make-up, and nails. A fully equipped fitness center with floor-to-ceiling windows makes the workouts less work, with a beautiful view to admire and a movement studio where Pilates Reformer, Spin, and Barre classes are available.

Lately, my workouts have been shoveling the snow off my front porch. But I am grateful for the ability to shake the little snow globe in my mind and gaze at the memory of the extraordinary solitude of the North Shore, the untouched beauty of this Polynesian paradise, the loving people I encountered who generously shared their history and culture, and the “shaka” spirit I packed in my bag and brought back home with me. Like the legend where the “Honu,” green turtles, guided the ancient peoples on how to get to the Hawaiian islands- these memories of Turtle Bay will guide me back.

L U X URY T R AV E L D E S T I N AT I ONS | S P EC I AL OF F ERS | REV IEWS

— P H YSI CIAN SO FFI CERESOURC E.COM/ MDESCAPES/ IN STAGRAM @ MDESCAPES

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MDe s c a p es feat u res exclus ive luxury travel d is co unts and o ffe r s ! Our g oa l i s to reward yo u, the healthcare p ro fessional, a n d h e l p p rov i d e t h e re st, ad venture, and memo ires that a ccom p a ny a luxury vacatio n.

FOUR SEASONS NEVIS FOUR SEASONS PUNTA MITA FOUR SEASONS NEW ORLEANS FOUR SEASONS SANTA FE CARTON HOUSE SANDESTIN GOLF AND BEACH RESORT AND MORE

— F IND YO U R ES CA PE AT Phys icians Of ficeRe sou rce.com / M D e scape s

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We recognize your passion for providing high quality care to patients displaying symptoms associated with respiratory infections, and we appreciate your efforts and resiliency working to reduce the number of people impacted by their spontaneous and rapid spread.

At SEKISUI Diagnostics we are committed to providing high quality, point-of-care tests for detecting the most common causes of respiratory infections, so you can get the answers fast and your patients back to doing what they love.

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